Cosmetic products Methods of analysis - Leffingwell

1 The rules governing Cosmetic productsin the European UnionVolume 2 Cosmetics legislationCosmetic productsMethods of analysis1999 EditionEUROPEAN COMMISSIONE nterprise Directorate-GeneralPharmaceuticals and cosmeticsTHE RULES GOVERNING Cosmetic PRODUCTSIN THE EUROPEAN UNIONV olume 1 Cosmetics legislationCosmetic productsVolume 2 Methods of analysisCosmetic productsVolume 3 GuidelinesCosmetic productsiiiFOREWORDIn the early 1970 s, the Member States of the EU decided to harmonise their national cosmeticregulations in order to enable the free circulation of Cosmetic products within the Community.

2 Asa result of numerous discussions between experts from all Member States, Council Directive76/768/EEC was adopted on 27 July 1976. The principles laid down in the Cosmetics Directivetake into account the needs of the consumer while encouraging commercial exchange andeliminating barriers to trade. For example, if a product is to move freely within the EU, the samelabelling, packaging and safety regulations must apply. This is one of the main objectives of theCosmetics Directive: to give clear guidance on what requirements a safe Cosmetic product shouldfulfil in order to freely circulate within the EU, without pre-market authorisation.

3 The CosmeticsDirective aims to guarantee the safety of Cosmetic products for human use. This safety relates tocomposition, packaging and information and it falls totally under the responsibility of theproducer or the importer into the EU who is responsible for the marketing liability. There is nopre-market control for Cosmetic products at Member State or EU level. Control of cosmeticproducts within the EU is assured through the responsibility of the person who places the producton the market, a simple notification of manufacturing/importing site.

4 And an in-marketsurveillance 2 of the series entitled The Rules governing Cosmetic products in the European Union incorporates the seven Commission Directives on the approximation of the laws of the MemberStates relating to Methods of analysis necessary for checking the composition of 76/768/EEC provides for the official testing of Cosmetic products with the aim ofensuring that the conditions prescribed pursuant to Community provisions concerning thecomposition of the Cosmetic products are satisfied.

5 Effective in-market control by Member Statesensures that only Cosmetic products which conform to the provisions of the Cosmetics Directiveand its Annexes are on the market. Inspectors appointed at national level may visit departmentstores, supermarkets, small shops and market stalls to check the products being sold. Ifnecessary, these inspectors may take any product from the market to official laboratories to betested for compliance with EU regulations. Article 8 (1) of Directive 76/768/EEC provides for thedetermination of the Methods of analysis necessary for checking the composition of cosmeticproducts.

6 A certain number of Methods of analysis have already been validated at European leveland accepted as official Methods and described in seven Commission Directives on theapproximation of the laws of the Member States relating to Methods of analysis necessary forchecking the composition of Cosmetic products . This means that official testing of cosmeticproducts by laboratories of any kind (national, control, etc.) have to be carried out in accordancewith the European official Methods described in these Directives 80/1335/EEC and 82/434/EEC have already been amended oncerespectively by Commission Directive 87/143/EEC and Commission Directive 90/207/EEC.

7 With aview to facilitating consultation, there are set out here in codified form for internal use by thecompetent Commission departments. These codified texts are available to the public but have noforce in law. Where doubts exist, the original texts as published in the Official Journal of theEuropean Communities, should be OF COMMISSION DIRECTIVE 80/1335 Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of thelaws of the Member States relating to Methods of analysis necessary for checking thecomposition of Cosmetic COMMISSION DIRECTIVE 82/434 Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the lawsof the Member States relating to Methods of analysis necessary for checking thecomposition of Cosmetic COMMISSION DIRECTIVE 83/514

8 Commission Directive 83/514/EEC of 27 September 1983 on the approximation of thelaws of the Member States relating to Methods of analysis necessary for checking thecomposition of Cosmetic COMMISSION DIRECTIVE 85/490 105 Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of thelaws of the Member States relating to Methods of analysis necessary for checking thecomposition of Cosmetic COMMISSION DIRECTIVE 93/73 129 Fifth Commission Directive 93/73/EEC of 9 September 1993 on the Methods of analysisnecessary for checking composition of Cosmetic COMMISSION DIRECTIVE 95/32 157 Sixth Commission Directive 95/32/EC of 7 July 1995 relating to Methods of analysisnecessary for checking the composition of Cosmetic COMMISSION DIRECTIVE 96/45 177 Seventh Commission Directive 96/45/EC of 2 July 1996 relating to Methods of analysisnecessary for checking the composition of Cosmetic

9 COMMISSION DIRECTIVE 80/1335/EECF irst Commission Directive 80/1335/EEC of 22 December 1980on the approximation of the laws of the Member States relatingto Methods of analysis necessary for checking the compositionof Cosmetic products (As amended by Commission Directive 87/143/EEC of 10 February 1987)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Economic Community,Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the lawsof the Member States relating to Cosmetic products (1), as amended by Directive 79/661/EEC (2),and in particular Article 8 (1)

10 Thereof,Whereas Directive 76/768/EEC provides for the official testing of Cosmetic products with the aimof ensuring that the conditions prescribed pursuant to Community provisions concerning thecomposition of the Cosmetic products are satisfied;Whereas all the necessary Methods of analysis must be established as soon as possible; whereasthe laying down of Methods for the sampling, laboratory preparation, identification anddetermination of free sodium and potassium hydroxides, the identification and determination ofoxalic acid and alkaline salts thereof in hair care products , the determination of chloroform intoothpastes and of zinc, and the identification and determination of phenosulfonic acid constitutesa first step in this direction.